NCT00324519

Brief Summary

The purpose of this study is to compare two methods of pregnancy termination on the time to delivery in the second trimester.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

March 5, 2012

Status Verified

March 1, 2012

Enrollment Period

2.2 years

First QC Date

May 10, 2006

Last Update Submit

March 1, 2012

Conditions

Pregnancy Trimester, SecondInduced Abortion

Keywords

second trimesterpregnancy terminationmisoprostolfoley bulb

Outcome Measures

Primary Outcomes (1)

  • Time to vaginal delivery

Secondary Outcomes (3)

  • Rate of chorioamnionitis

  • Rate of maternal fever

  • Rate of postpartum hemorrhage

Study Arms (2)

Misoprostol Drug

ACTIVE COMPARATOR

This is the misoprostol drug.

Drug: misoprostol

The Foley Bulb

EXPERIMENTAL

This is the experimental portion to test the Foley Bulb.

Device: Foley bulb

Interventions

Foley bulbDEVICE
The Foley Bulb
misoprostolDRUG
Misoprostol Drug

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • indication for pregnancy termination, gestational age from 13-27 weeks

You may not qualify if:

  • multiple gestation, previous uterine surgery, rupture of membranes, latex allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shands Hospital at the University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Keri A Baacke, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 11, 2006

Study Start

February 1, 2005

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

March 5, 2012

Record last verified: 2012-03

Locations

US(1)